MAUDE Adverse Event Report: MASIMO - 40 PARKER M-LNCS DB-I; OXIMETER

Model Number	2507
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Event or Problem Description
The customer reported a loose connection.The colleagues from our customer service indicated this error as ¿defective connection".That's why the connection is interrupted from time to time.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
The returned sensor was evaluated.Visual inspection confirmed there was no physical damage.During evaluation the unit failed continuity testing due to an open in the cable on the white conductor, inside the bend relief area of the m15 connector.Open in the cable was most likely due to sharp/tight bent based upon the appearance of the conductor jacket and location of the open.The sensor provided a "sensor off patient" error message during functionality testing using known good lab monitor, lab cable, and finger with the returned sensor.

• Brand Name: M-LNCS DB-I
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• MDR Report Key: 6823314
• Report Number: 2031172-2017-00828
• Device Sequence Number: 1324140
• Product Code: DQA
• UDI-Device Identifier: 00843997003698
• UDI-Public: 00843997003698
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2507
• Device Catalogue Number: 2507
• Device Lot Number: K16N44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 09/07/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1